WO2007059160A2 - Prothese multifocale, et procedes de fabrication et d'utilisation de celle-ci - Google Patents

Prothese multifocale, et procedes de fabrication et d'utilisation de celle-ci Download PDF

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Publication number
WO2007059160A2
WO2007059160A2 PCT/US2006/044245 US2006044245W WO2007059160A2 WO 2007059160 A2 WO2007059160 A2 WO 2007059160A2 US 2006044245 W US2006044245 W US 2006044245W WO 2007059160 A2 WO2007059160 A2 WO 2007059160A2
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WO
WIPO (PCT)
Prior art keywords
prosthesis
lens
optical axis
fluid
chamber
Prior art date
Application number
PCT/US2006/044245
Other languages
English (en)
Other versions
WO2007059160A3 (fr
Inventor
Alan N. Glazier
Original Assignee
Vision Solutions Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vision Solutions Technologies, Inc. filed Critical Vision Solutions Technologies, Inc.
Priority to EP06837602A priority Critical patent/EP1954213A4/fr
Priority to CA002631261A priority patent/CA2631261A1/fr
Priority to JP2008541290A priority patent/JP4931932B2/ja
Publication of WO2007059160A2 publication Critical patent/WO2007059160A2/fr
Publication of WO2007059160A3 publication Critical patent/WO2007059160A3/fr
Priority to US12/047,164 priority patent/US8657877B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1648—Multipart lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1627—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing index of refraction, e.g. by external means or by tilting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0053—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in optical properties

Definitions

  • TITLE MULTI-FOCAL PROSTHESIS, AND METHODS FOR MAKING AND USING SAME
  • This invention relates generally to the use of a prosthesis for treatment of retinal degenerative conditions (e.g., low vision, macular degeneration), and other conditions and surgical procedures involving the eyes, especially human eyes.
  • retinal degenerative conditions e.g., low vision, macular degeneration
  • the most outwardly visible structures of the human eye include an optically clear anterior cornea, the iris sphincter sitting behind the cornea, and the iris aperture, which is referred to as the pupil.
  • the pupil appears as a circular opening concentrically inward of the iris.
  • Light passes through the pupil along a path to the retina in the back of the eye.
  • a physiological crystalline lens in a capsular bag is positioned posterior to the iris.
  • the chamber between the posterior cornea and the front surface of the capsular bag is commonly referred to as the anterior chamber.
  • a posterior chamber is the area behind the anterior chamber, and includes the capsular bag and physiological crystalline lens.
  • Ciliary muscle concentrically surrounds the capsular bag, and is coupled to the physiological crystalline lens by suspensory ligaments, also known as zonules.
  • Vitreous humor is contained in the posterior chamber behind the capsular bag.
  • the vitreous humor is surrounded by the retina, which is surrounded by the sclera.
  • a young and healthy physiological lens of the human eye has sufficient elasticity to provide the eye with natural accommodation ability.
  • a young elastic lens may alter its shape, by a process known as accommodation, to change refractive power.
  • accommodation refers to the ability of the eye to adjust focus between the distant point of focus, called the Punctum Remotum o ⁇ pr (far point beyond 20 feet or 6 meters away), and the near point of focus called the Punctum Proximum or pp (near point within 20 feet or 6 meters away from the eye). Focus adjustment is performed in a young elastic lens using the accommodative- convergence mechanism.
  • the ciliary muscle functions to shape the curvature of the physiological crystalline lens to an appropriate optical configuration for focusing and converging light rays entering the eye on the fovea of the retina. It is widely believed that this accommodation is accomplished via contracting and relaxing the ciliary muscles, which accommodate the lens of the eye for near and distant vision, respectively.
  • a retinal degenerative condition adversely affects an individual's eyesight, both at near and far vision.
  • an RDC involves damage to the fovea.
  • An RDC such as macular degeneration leaves the afflicted individual with a "blind spot" or scotoma usually at or near the center of a person's visual field.
  • the afflicted individual is often only able to see peripheral images around the blind spot.
  • the visual field provided by such peripheral images is often insufficient to allow the individual to perform routine activities such as reading, driving a vehicle, or even daily chores and errands.
  • the individual when an individual having a RDC attempts to recognize another person at a distance, the individual may be able to discern the eccentric body portions of the viewed person peripherally, but the scotoma may "wipe out" the facial details of the viewed person, rendering the person unrecognizable.
  • a person who suffers from a RDC is typically treated optically by using magnification or prism in lens form.
  • a Galilean telescopic magnifying device may be placed in front of the eye or in the eye and customized to the user's needs. The magnification of the device enlarges the image viewed, expanding the image into more healthy areas of retina peripheral (eccentric) to the scotoma.
  • the person suffering from a RDC usually needs magnification in the form of magnifying plus powered lenses and/or prisms - the former (i.e., the plus lenses and magnifiers) to help enlarge the image outside of the scotoma as in the telescopic example and the latter (e.g., the prisms) to help shift the images to different, more functional areas of the retina.
  • the former i.e., the plus lenses and magnifiers
  • the prisms e.g., the prisms
  • Devices used to provide magnification at distance and near are prescribed according to the art and science of "low-vision".
  • An example of a low vision device for distance use is a spectacle-mounted telescopic device.
  • An example of a low vision device for near use is a hand-held magnification device and/or prism to assist the user in accessing retinal area peripheral to the damaged area responsible for producing the scotoma.
  • Devices used to provide magnification at distance and near have several drawbacks. First of all, the devices are heavy and bulky, making them difficult to use from an ergonomic perspective. Second, the devices, such as those mounted on a pair of spectacles, may be considered aesthetically unappealing by some.
  • telescopic devices outside of the eye may distort (e.g., create aberrations, astigmatism) or decrease the effectiveness of magnification, for example, in the case of spectacle-mounted telescopic devices in which there exists a vertex distance (the distance from the back of the lens to the front of the cornea).
  • current implantable telescopic lenses are held within bulky housings, which decrease the user's peripheral vision and result in a significant loss in the user's field of vision.
  • the devices are often housed in a hand held device, which requires the user to not have "hands free” use of the device - i.e., the user may have trouble holding a newspaper or book in one hand and a device in the other.
  • An object of this invention is to provide prosthesis, such as but not necessarily limited to an intraocular lens (IOL), useful for reducing the effects of a scotomatous area in a field of vision of a person having a retinal degenerative disorder.
  • IOL intraocular lens
  • Another object of this invention is to provide a prosthesis that reduces the adverse effects of RDCs while permitting the user to shift between near and far vision by natural tilting movement of the head and/or eye, preferably smoothly and without significant disruption to the field of vision.
  • a first aspect of the invention features a prosthesis including at least a positive lens, a negative lens in alignment with and spaced from the positive lens, and an optic body supporting the positive lens and the negative lens in spaced relation to one another to establish a chamber between the lenses.
  • Optically transmissive primary and secondary fluids are contained in the chamber of the optic body.
  • the primary fluid is immiscible with and has a different density and refractive index than the secondary fluid.
  • the prosthesis comprises an intraocular lens implantable into a human eye, wherein the positive lens and the negative lens are an objective lens for facing the anterior side and an ocular lens for facing the posterior side of the human eye, respectively.
  • the objective and ocular lenses optionally are arranged with respect to one another to collectively establish a Galilean system.
  • the prosthesis comprises an intraocular lens implantable into a human eye, wherein the positive lens and the negative lens are an ocular lens for facing the posterior side of the human eye and an objective lens for facing the anterior side of the human eye, respectively.
  • the objective and ocular lenses optionally are arranged with respect to one another to collectively establish a reverse Galilean system.
  • a method for optically altering an image.
  • the method features viewing an object through the prosthesis.
  • the prosthesis includes at least a positive lens, a negative lens in alignment with and spaced from the positive lens, and an optic body supporting the positive lens and the negative lens in spaced relation to one another to establish a chamber between the lenses.
  • Optically transmissive primary and secondary fluids are contained in the chamber of the optic body.
  • the primary fluid is immiscible with and has a different density and refractive index than the secondary fluid.
  • the prosthesis comprises an intraocular lens implanted into a human eye, wherein the positive lens and the negative lens are an objective lens facing the anterior side of the human eye and an ocular lens facing the posterior side of the human eye, respectively.
  • the objective and ocular lenses optionally are arranged with respect to one another to collectively establish a Galilean system.
  • the prosthesis comprises an intraocular lens implantable into a human eye, wherein the positive lens and the negative lens are an ocular lens facing the posterior side of the human eye and an objective lens facing the anterior side of the human eye, respectively.
  • the objective and ocular lenses optionally are arranged with respect to one another to collectively establish a reverse Galilean system.
  • a third aspect of the invention features a prosthesis including first and second lenses in alignment with one another, and an optic body supporting the first and second lenses in spaced relation to one another to establish a chamber between the lenses.
  • Optically transmissive primary and secondary fluids are contained in the chamber of the optic body.
  • the primary fluid is immiscible with and has a different density and refractive index than the secondary fluid.
  • the prosthesis further comprises an internal plate positioned within the chamber between the positive and negative lenses, wherein the internal plate has substantially planar, substantially parallel opposite surfaces facing the first and second lenses, respectively.
  • a method for optically altering an image.
  • the method features viewing an object through a prosthesis.
  • the prosthesis includes first and second lenses in alignment with one another, and an optic body supporting the first and second lenses in spaced relation to one another to establish a chamber between the lenses.
  • Optically transmissive primary and secondary fluids are contained in the chamber of the optic body.
  • the primary fluid is immiscible with and has a different density and refractive index than the secondary fluid.
  • the prosthesis further comprises an internal plate positioned within the chamber between the positive and negative lenses, wherein the internal plate has substantially planar, substantially parallel opposite surfaces facing the first and second lenses, respectively.
  • multi-focus vision may be achieved by the natural motion of the user's eye and/or head.
  • the user gazes straight ahead to orient the optical axis substantially parallel to the horizon.
  • the optical axis passes through (or intersects) the optically transmissive primary fluid, but not the secondary fluid.
  • the refractive index of the primary fluid through which the optical axis passes and the curvature of the positive and negative lenses alter the effective power of the prosthesis for focusing.
  • the primary and secondary fluids move relative to the lens body to cause the optical axis (and visual axis) to pass through (or intersect) both the fluids.
  • the combined refractive indexes of the primary and secondary fluids and the curvature of the positive and negative lenses alter the effective power of the lens for focusing on near objects (at Hhspp).
  • the position of the eye and the angle of the optical axis of the prosthesis relative to the horizon changes. This tilting movement alters the power of the lens by intercepting both of the fluids with the optical axis.
  • the effective power of the prosthesis is returned to normal as the optical axis returns to the horizontal orientation and the secondary fluid is removed from interception with the optical axis.
  • the telescopic optics preferably magnify the image desired to be viewed beyond the borders of the damaged region of the retina (or macula) which is responsible for the scotoma, i.e., into healthy areas of the central retina.
  • the viewed object preferably is optically altered, e.g., shifted or magnified, so that a greater percentage of the object is viewed peripheral to (i.e., outside of) the scotoma.
  • the adjustment in effective power of the prosthesis is achieved without any moving parts (other than the flow of the refractive fluids) and optionally without requiring the division of the prosthesis into separate compartments via internal channels that prevent or inhibit elastic deformation of the prosthesis.
  • the primary fluid and the secondary fluid may comprise a first liquid and a second liquid, respectively.
  • either of the fluids may be a gas, a mixture of gases, or vacuum.
  • the first density is greater than the second density.
  • the second density may be greater than the first density.
  • FIG. 1 is a schematic representation of a human eye with a posterior chamber containing a prosthesis in which the eye is gazing straight ahead at the horizon;
  • FIG. 2 is a schematic representation of the human eye containing the prosthesis of Fig. 1, in which the eye is angled downward in a reading position;
  • FIG. 3 is a schematic, enlarged view of the prosthesis of a first embodiment of the invention, depicting the prosthesis oriented in straight-ahead gaze;
  • Fig. 4 is a schematic, enlarged view of the prosthesis of Fig 3, depicting the prosthesis oriented in the reading position;
  • Fig. 5 is a schematic, enlarged view of a prosthesis according to a second embodiment of this invention, depicting the prosthesis in the posterior chamber of the eye oriented in a straight-ahead gaze;
  • FIG. 6 is a schematic, enlarged view of the prosthesis of the second embodiment of this invention, depicting the prosthesis angled downward in a reading position;
  • FIG. 7 is a simplified illustration of a prosthesis optic body set on a Cartesian coordinate system
  • FIG. 8 shows an example of a Galilean telescopic system
  • Fig. 9 is a front view of modifications to the embodied prosthesis.
  • FIGS. 10 and 11 are side sectional views of Fig. 9 according to respective modified embodiments of the invention.
  • Figs. 12-14 relate to examples reported below;
  • FIG. 15 is a schematic, enlarged view of the prosthesis of a third embodiment of the invention, depicting the prosthesis oriented in straight-ahead gaze;
  • Fig. 16 is a schematic, enlarged view of the prosthesis of Fig. 15, depicting the prosthesis oriented in the reading position;
  • FIGs. 17-20 are schematic views of a modification to the prosthesis
  • Fig. 21 is a schematic of still another embodiment of the invention.
  • Figs. 1-4 illustrate a prosthesis, which is depicted in several of the drawings as an intraocular lens (IOL), generally designated by reference numeral 110, according to a first preferred embodiment of this invention.
  • Prosthesis 110 comprises an optic body 112, which for the purpose of the IOL illustrated in Figs. 1-4 is sized and configured to be received in the capsular bag 160 of a human eye 150.
  • Optic body 112 supports a positive objective lens 114 and a negative ocular lens 116 in alignment with and spaced behind objective lens 114.
  • a chamber 118 is established between lenses 114, 116 within optic body 112.
  • Chamber 118 is preferably enclosed between lenses 114, 116 within optic body 112, and more preferably is enclosed by a structure consisting of lenses 114, 116 and optic body 112.
  • Lenses 114, 116 maybe, for example, either made as a unitary "integral" piece of optic body 112 or may be formed as separate members joined together with optic body 112.
  • An optical axis 120 intersects objective lens 114 at a front vertex and ocular lens 116 at a rear vertex.
  • Lenses 114, 116 are preferably spherical, although each may be aspheric, and may be produced or modified into an aspheric shape or otherwise to compensate for astigmatism, coma, and higher order aberrations, including double images induced by prism.
  • lens 114 is convex-convex and ocular lens 116 is concave-concave.
  • ocular lens 116 is concave-concave.
  • lens 114, 116 may have a non-curved or flat surface with a radius of curvature equal to zero, e.g., convex-flat, flat-convex, concave-flat, or flat-concave.
  • Lens 114 and/or 16 may have a combination of convex and concave surfaces, e.g., concave-convex or convex-concave, shaped to provide the desired effective power and refractive properties.
  • lenses 114 and/or ocular lenses 116 are also within the scope of the invention. It is also within the scope of the invention to use multiple objective lenses 114 and/or ocular lenses 116, and/or to have either or both of lenses 114, 116 comprised of laminates. Another possibility is to employ lenses 114, 116 with discrete refractive zones, especially concentric zones, such as in the case of Fresnel magnification.
  • Optic body 112 of this first embodiment and other embodiments described herein is optionally, although not necessarily, free of interior and exterior channels, especially those that would prevent the deforming or folding of optic body 112 during surgical insertion.
  • An optically transmissive upper fluid 122 and an optically transmissive lower liquid 124 are contained in chamber 118 of optic body 112. It is possible in this and other embodiments of the invention that upper fluid 122 be a liquid or mixture of liquids, and that the liquids 122 and 124 fill the entire chamber 118, thereby eliminating any gases or free space within the chamber 118. Alternatively, upper fluid 122 may be a gas or mixture of gases, including air, or a vacuum. Lower liquid 124 is denser than and has a different refractive index than upper fluid 122. Upper and lower fluids 122, 124 are substantially immiscible with one another.
  • substantially immiscible means that upper and lower fluids undergo no or sufficiently small amounts of intermixing so that the function of the refractive fluids is performed, i.e., multi-focal sight is obtained by physical tilting of prosthetic 110.
  • Eye 150 includes optically transmissive cornea 152, behind which is iris 154.
  • the pupil (unnumbered) is interior to iris 154 and commonly appears as a black circular area concentrically inward of iris 154 when viewed from directly in front of eye 150.
  • Posterior chamber 158 of eye 150 includes capsular bag 160, which is shown in this embodiment holding intraocular lens 110.
  • the chamber between cornea 152 and the front surface of capsular bag 160, as shown in Figs. 1 and 2 is commonly referred to in the art as anterior chamber 156.
  • Ciliary muscle 162 surrounds capsular bag 160, and is coupled to the physiological crystalline lens (not shown) by zonules.
  • the portion of posterior chamber 158 behind capsular bag 160 contains vitreous humor, which is interior to sclera 168.
  • the conjunctiva (not shown) coats sclera 168.
  • Light entering the human eye is converged on retina 170 at macula 172, via the optics of cornea 152 and intraocular lens 110.
  • the light rays are bent or refracted to converge at a point at macula 172 of retina 170 to provide a clear image.
  • Optical axis 120 is situated in optic body 112 for placement along a light path 121 that enters through and is initially refracted by cornea 152, then passes through the pupil to retina 170.
  • An optically transmissive anterior visual zone of objective lens 114 defines an area through which the light path intersects lens 114.
  • An optically transmissive posterior visual zone of ocular lens 116 defines an area through which the light path intersects lens 116.
  • the visual zones may be coextensive with the outer perimeters of lenses 114, 116,- the visual zones are more typically smaller in diameter and concentric with the outer perimeters of lenses 114, 116.
  • iris 154 functions to filter or block a portion of the light that passes through cornea 152.
  • the light path through a posterior chamber lens represents the portion of the light that enters through the tear film (not shown) and cornea 152, passes through the pupil and is refracted by prosthesis 110 to retina 172.
  • Fig. 3 shows prosthesis 110 of the first embodiment of this invention positioned in posterior chamber 158 of eye 150 gazing straight ahead at the pr.
  • optical axis 120 is parallel to axis along horizontal plane 180, or in a horizontal orientation.
  • Horizontal plane 180 is shown in Fig. 2.
  • the eye is usually not rotationally symmetric, so that the optical axis and the visual axis are not co-linear.
  • the straight-ahead gaze refers to the position at which the optical axis is oriented horizontally.
  • Optically transmissive lower liquid 124 is present in a sufficient amount that orienting optical axis 120 in the horizontal orientation for distant vision positions optical axis 120 through lower liquid 124.
  • anterior visual zone and the posterior visual zone of lenses 114, 116, respectively are immersed in lower liquid 124. Because the anterior visual zone and posterior visual zone are typically substantially concentric about the front vertex and the rear vertex, contact interface 123 between lower liquid 124 and upper fluid 122 is above the vertexes in the straight-ahead gaze.
  • lower liquid 124 is present in a sufficient amount that in the straight-ahead gaze at least 70 percent, and more preferably all, of the anterior and posterior visual zones and are immersed in lower liquid.
  • light entering prosthesis 110 travels along optical axis 120 and is primarily refracted by denser lower liquid 124.
  • any distortion caused by the presence of the fluid interface 123 between the anterior or posterior visual zone will be minor and appear as glare to the extent it is even noticeable.
  • the curvatures of lenses 114, 116 are calculated to account for the refractive index of lower liquid 124 such that light traveling through eye 150 from the Punctum Remotum may be focused on macula 172.
  • the radii of curvature of lenses 114, 116 may be selected depending upon the specific upper and lower fluids 122, 124 chosen and the desired amount of accommodation.
  • optical axis 120 rotates to an angle ⁇ relative to the horizontal 180, as shown in Fig. 4.
  • optic body 112 is shown in a straight-ahead gaze centered on a Cartesian coordinate system.
  • Optic body 112 has width (w), height (h), and depth (d) on the x, y, and z-axes, respectively.
  • optical axis 120 front vertex 114a and rear vertex 114b rest on the z-axis.
  • the down gaze involves displacement of the optical axis relative to the horizontal or z-axis by a range of effective angles ⁇ to accomplish the objects of this invention.
  • the effective angles ⁇ may comprise angles throughout a range of 70-90 degrees, more preferably throughout a range of 45-90 degrees, and in some cases as large as angles throughout a range of 30-90 degrees. (It should be understood that the natural tilting movement of the human head and/or eye does not pivot the prosthesis about a stationary x axis.)
  • optical axis 120 of this first embodiment is positioned at an angle ⁇ relative to horizontal 180.
  • Upper fluid 122 is present in chamber 118 in a sufficient amount that, throughout a range of effective angles ⁇ , upper fluid 122 is translated down ocular lens 116 so that the optical axis 120 extends through the upper fluid 122 at the vertex of ocular lens 116.
  • most of the anterior visual zone of objective lens 114 is immersed in lower liquid 124, and most of the posterior visual zone of ocular lens 116 is immersed in upper fluid 122. More preferably, at the effective angles ⁇ the anterior visual zone of lens 114 has at least 70 percent of its surface area immersed in lower liquid 124.
  • the term "most” may mean “all,” in which case the anterior visual zone of lens 114 has 100 percent of its surface area immersed in lower liquid 124. (For the purposes of determining the percent immersed surface area, the anterior and posterior visual zones may be assumed to be those for an IOL of this invention implanted into an adult human emmetrope modeled as described in the Optical Society of America Handbook.) Simultaneously, at the effective angles ⁇ the posterior visual zone of lens 116 preferably has at least 70 percent of its surface area, and more preferably all (100 percent) of its surface area, immersed in upper fluid 122.
  • the substantially immiscible fluids/liquids have a sufficiently low viscosity to permit them to freely translate at substantially the same time one's gaze changes from far-to-near and near-to-far.
  • the fluids/liquids translate back to the primary position shown in Figs. 1 and 3.
  • the light rays that focus on thepr pass primarily through lower liquid 124.
  • the change in power is created without the need for convexity change (e.g., flexing) of lenses 114, 116 or optic body 112.
  • the change in power is also accomplished without moving prosthesis 110 relative to eye 150, i.e., towards or away from macula 172.
  • upper liquid 122 is displaced into the visual axis to provide the desired amount of accommodation for near, e.g., 3 to 9 inches from the eye.
  • IOL 110 adjusts back to distance focus as straight-ahead gaze is restored.
  • the range of effective angles ⁇ at which upper fluid 122 immerses a majority of the surface area of the posterior visual zone of lens 116 is dependent upon the relative amounts of upper fluid 122 and lower liquid 124 in chamber 118.
  • Other factors, such as lens thickness, lens radius, and volume shaping, may also affect the effective angle ⁇ .
  • the width (w), height (h), and depth (d) of optic body 112 will depend upon several factors, including the sizes of the patient's physiological lens, anterior chamber, and posterior chamber.
  • the width (w) and height (h) of optic body 112 may be, for example, in a range of 2.5 mm to 10 mm, more commonly 4.0 mm to 7.5 mm.
  • the width (w) and height (h) are preferably, but not necessarily, the same in dimension.
  • the depth (d) or thickness of optic body 112 should not be so great as to inhibit implantation into eye 150. On the other hand, the depth is preferably not so small as to inhibit fluid translation in chamber 118 of optic body 112.
  • the depth (d) may be, for example, at least 0.9 mm.
  • Anterior visual zone of objective lens 114 and the posterior visual zone of ocular lens 116 are typically centered concentrically with the front vertex and the rear vertex.
  • the anterior visual zone and the posterior visual zone in an average human eye are about 2 mm to 7 mm in diameter, depending upon the size of the pupil.
  • prosthesis 110 may be implanted in the anterior chamber 156.
  • Prosthesis 110 in anterior chamber 156 may be the sole lens in the eye, or may supplement a physiological or synthetic lens placed in posterior chamber 158.
  • An anterior chamber implantation may be located between the cornea and the front of iris 154 or between iris 154 and the front surface of capsular bag 160. The anterior chamber implantation may be anchored to the iris or in the angle recess.
  • prosthesis 110 may extend through the pupil.
  • prosthesis 110 may be an exterior device applied outside of the eye, for example, mounted on frames or eyeglasses in front of eye 150.
  • Prosthesis 110 may be used in combination with a physiological or synthetic lens placed in the anterior and/or posterior chamber(s).
  • Such as external prosthesis 110 may have greater dimensions than described above, since external prosthesis 110 need not be implantable into eye 150.
  • prosthesis 210 of the second embodiment comprises an optic body 212 receivable in the capsular bag of a human eye.
  • Optic body 212 comprises a positive objective lens 214 facing the anterior side of the human eye, a negative ocular lens 216 in alignment with and spaced behind objective lens 214 to face the posterior side of the human eye.
  • a chamber 218 is present between lenses 214, 216 within prosthesis 210.
  • An optical axis 220 of optic body 212 intersects objective lens 214 at a front vertex and ocular lens 216 at a rear vertex.
  • prosthesis 210 is illustrated as an internal lens designed for placement in the posterior chamber or anterior chamber of a human eye.
  • prosthesis 210 may serve as an exterior device for placement outside of the human eye, in which case prosthesis 210 may be rescaled and enlarged.
  • Optical axis 220 is situated for placement in the human eye along a light path, which passes through the pupil to retina 270. The light path intersects objective lens 214 at an optically transmissive anterior visual zone of lens 214, and the light intersects ocular lens 216 at an optically transmissive posterior visual zone of ocular lens 216.
  • Fig. 5 shows intraocular lens 210 positioned in posterior chamber 258 of the eye gazing straight ahead at thepr.
  • optical axis 220 is parallel to the axis along the horizontal plane.
  • Optically transmissive lower liquid 224 is present in a sufficient amount that orienting optical axis 220 in a horizontal orientation positions optical axis 220 through upper fluid 222, and most of the anterior visual zone of lens 214 and the posterior visual zone of lens 216 are immersed in the upper fluid 222.
  • upper fluid 222 is present in a sufficient amount that in the straight-ahead gaze at least 70 percent, and more preferably all, of the anterior and posterior visual zones of lenses 214, 216 are immersed in upper fluid 222.
  • light entering IOL 210 travels along the optical axis and is primarily refracted by upper fluid 222. It is believed that any distortion caused by the presence of fluid interface (i.e., plane of contact) 223 would be minor and appear as glare, to the extent it appears at all.
  • the curvatures of lenses 214, 216 are calculated to account for the refractive index of upper fluid 222 such that light traveling through the eye from the Punctum Remotum may be focused on macula 272 of the eye.
  • the radii of curvature of lenses 214, 216 may be selected depending upon the specific upper fluid 222 and lower liquid 224 chosen and the desired amount of accommodation. It is within the scope of the invention to form a lens which is capable of translating to any desired power for accommodation of eyesight, whether more (+) power or more (-) power upon down gaze.
  • optical axis 220 of this second embodiment is positioned at an angle ⁇ relative to horizontal to translate lower liquid 224 higher on lens 214.
  • Lower liquid 224 is present in chamber 218 in a sufficient amount that, at the effective angles ⁇ , optical axis 220 extends through lower liquid 224 at the front vertex and upper fluid 222 at the back vertex.
  • most of the anterior visual zone is immersed in lower liquid 224, and most of the posterior visual zone is immersed in upper fluid 222.
  • the anterior visual zone of lens 214 has at least 70 percent of its area, and more preferably 100 percent of its area, immersed in lower liquid 224.
  • the posterior visual zone preferably has at least 70 percent of its area, and more preferably 100 percent of its area, immersed in upper fluid 222.
  • the light rays first travel through lower liquid 224 bathing the anterior visual zone of ocular lens 214 before traveling through contact interface 223 and upper fluid 222 bathing the posterior visual zone of ocular lens 216, thereafter reaching macula 272. Because upper fluid 222 and lower liquid 224 differ in refractive indices, upper fluid 22 and lower liquid 224 will refract the light differently.
  • the range of effective angles ⁇ necessary for displacing lower fluid 222 to contact the front vertex of objective lens 214 is dependent upon the relative amounts of upper fluid 222 and lower liquid 224 in chamber 218.
  • low levels of lower liquid 224 generally will require greater effective angles ⁇ for contacting lower liquid 224 with lens 214.
  • a sufficient amount of lower liquid 224 is present in this second embodiment that the bi-focal effect is realized throughout at least a range of effective angles of 70-90 degrees.
  • One particularly advantageous feature embodied in certain aspects of this invention is that orientation of the optical axis perpendicular to the horizon, so that the patient's head is directed straight downward, causes the optical axis to pass through both the upper fluid and the lower liquid, thereby accommodating for near- sight. This advantage makes this and other embodiments of the invention especially useful for reading.
  • prosthesis 210 of this second embodiment is illustrated as an internal lens implanted in posterior chamber 258 of the eye, it is to be understood that prosthesis 210 may be implanted in anterior chamber 256.
  • Theprosthesis in the anterior chamber may be the sole lens in the eye, or may supplement a physiological or synthetic lens placed in posterior chamber 258.
  • Prosthesis 210 may be placed between the cornea and the iris, between the iris and the capsular bag, or through the pupil.
  • prosthesis 210 may be an exterior device applied outside of the eye, for example, mounted on frames or eyeglasses in front of eye 250.
  • Prosthesis 210 may be used in combination with a physiological or synthetic lens placed in the anterior and/or posterior chamber(s).
  • Such as external prosthesis 210 may have greater dimensions than described above, since external prosthesis 210 need not be implantable into eye 250.
  • the prosthesis of this invention can be used for various eye conditions and diseases, including, for example, aphakia, pseudophakia, anterior cortical cataract extraction (acce), posterior cortical cataract extraction (pcce), and the like.
  • the intraocular lens embodied above is useful for treating retinal degenerative conditions (or "low vision"), and more particularly for reducing the effects of a scotomatous area on a visual field of a person having a retinal degenerative condition.
  • treatment of RDCs is accomplished by designing the prosthesis of the present invention as a Galilean-type device, wherein the objective lens of prosthesis 110, 210 is located in front of the ocular lens of prosthesis 110, 210 for establishing a telescopic benefit and a near- magnifying benefit.
  • the telescopic benefit is derived from the effective power of the ocular lens being calculated to be negative in power, and the objective lens in front of the ocular lens being calculated to be positive in power.
  • the focal points and/or focal planes of the objective and ocular lenses are coincident with one another, as is the case in a Galilean telescope.
  • a "negative power” lens is a "diverging lens”, i.e., a lens having a cumulative effect of diverging light passing through the lens.
  • a "positive power” lens is a "converging lens", Le., a lens having a cumulative effect of converging light rays passing through the lens.
  • the power of the prosthesis is controlled through selection of the fluids and lens curvatures.
  • By controlling the negative power of the ocular lens and the positive power of the objective lens a desired magnification can be obtained.
  • the overall telescopic effect of the ocular and objective lens preferably is negative.
  • the prosthesis provides a near point Galilean low vision magnifier.
  • the telescopic effect of this preferred embodiment is instrumental in reducing the effects of a scotomatous area of an individual afflicted with a RDC.
  • the telescopic optics established by this preferred embodiment magnify the image desired to be viewed beyond the borders of the damaged region of the retina (and more particularly the macula) which is responsible for the scotoma, into healthy areas of the central retina.
  • the scotomatous area is not removed from the field of vision, the viewed object is shifted, magnified, or otherwise moved so that a greater percentage of the object is viewed outside of the scotoma.
  • a person with macular degeneration is provided with from about 1.5x to about 5.2x magnification (e.g., about 1.5x to about 5.0x). More preferably, in straight ahead gaze the magnification is about 1.5x to about 3.0x, and in down gaze the magnification is about 2.Ox to about 5.0x (e.g., about 3.0x to about 5.Ox).
  • the higher the magnification the smaller the user's field of view and, therefore, a balance must be reached. Preferably, this balance is dictated by the patient's pupil size, and in particular, maximizing the field of view for the particular pupil size.
  • the iris of the natural eye in essence functions as the "housing" of the ocular of the telescope, thereby removing the need for combining the intraocular lens with an artificial housing, such as those used in conventional implanted telescopic devices.
  • an artificial housing such as those used in conventional implanted telescopic devices.
  • omission of an artificial ocular housing can improve the field of vision of a person afflicted with a RDC.
  • the artificial housing of a telescope typically is sized and positioned away from the iris in such a manner as to limit the field of vision, providing a field of vision lesser than that obtainable by the naked eye.
  • the artificial housing of a telescope is not able to account for subtle variations in pupil size due to pupil dilation (e.g., for far vision) and pupil restriction (e.g., for near vision).
  • pupil dilation e.g., for far vision
  • pupil restriction e.g., for near vision
  • the user's field of view is not unduly restricted.
  • a prosthesis 310 comprises a positive objective lens 314, a negative ocular lens 316, and a chamber 318 between lenses 314, 316 within optic body 312.
  • Chamber 318 is preferably enclosed between lenses 314, 316 and optic body 312, and more preferably is enclosed by a structure consisting of lenses 314, 316, and body 312.
  • Lenses 314, 316 are preferably spherical as shown in Fig. 9, although each may be aspheric.
  • the front of optic body 312 includes an annular channel or trench 392, which constitutes part of chamber 318. In the illustrated embodiment, channel 392 extends 360° around the perimeter of the front interior of body 312.
  • channel 392 may extend only a portion of the way around the perimeter of the front interior of body 312, in which case channel 392 is preferably arcuate.
  • Chamber 318 includes an upper fluid 322 and a lower liquid 324.
  • upper fluid 322 of lower density is maintained in channel 392, out of contact with lenses 314, 316.
  • the optical path to the retina passes through lower liquid 324 while substantially avoiding upper fluid 322.
  • the optical path extends through lower fluid 324 at objective lens 314 and upper fluid 322 at objective lens 316.
  • Prosthesis 410 shown in Fig. 11 comprises a positive objective lens 414, a negative ocular lens 416, and a chamber 418 between lenses 414, 416 within optic body 412.
  • Chamber 418 is preferably enclosed between lenses 414, 416 and body 412, and more preferably is enclosed by a structure consisting of lenses 414, 416, and body 412.
  • Lenses 414, 416 are preferably spherical as shown in Fig. 9, although each may be aspheric.
  • the rear of body 412 includes an annular channel or trench 492, which constitutes part of chamber 418. In the illustrated embodiment, channel 492 extends 360° around the perimeter of the rear interior of optic body 412.
  • channel 492 may extend only a portion of the way around the perimeter of the rear interior of optic body 412, in which case channel 492 is preferably arcuate.
  • Chamber 418 includes an upper fluid 422 and a lower liquid 424.
  • lower fluid 424 of higher density is maintained in channel 492, out of contact with lenses 414, 416.
  • the optical path to the retina passes through upper liquid 422 while substantially avoiding lower fluid 424.
  • the optical path extends through lower fluid 424 at objective lens 414 and upper fluid 422 at objective lens 416, thereby providing the desired bi-focal effect.
  • haptics may be provided with a channel that communicates with the lens chamber.
  • Figs. 15 and 16 show an alternative embodiment of the invention in which intraocular lens 510 is inverted or reversed, so that objective lens 514 is negative and ocular lens 516 is positive.
  • This embodiment is especially useful in the treatment of retinitis pigmentosa, glaucoma, and other disorders in which reverse magnification is desired for improving vision of the user.
  • Figs. 15 and 16 show lower fluid 524 as the primary fluid, i.e., so that lower fluid 524 is intersected by the optical axis and upper fluid 522 is not intersected by the optical axis during straight ahead view. It should be understood that this embodiment may be modified to select upper fluid 522 as the primary fluid.
  • an intraocular lens 610 further comprises at least one internal plate (or baffle) 690.
  • Internal plate 690 may comprise, for example, a rigid material or a flexible material, such as a film.
  • Internal plate 690 preferably is optically transmissive, and more preferably transparent.
  • Plastics such as polymethmethacrylate (PMMA) are especially useful materials from which internal plate 690 may be made.
  • Internal plate 690 preferably is non-lenticular, and preferably has substantially flat, substantially parallel opposite sides to contribute substantially no refractive power to prosthesis 610.
  • Internal plate 690 preferably is arranged substantially perpendicular to optical axis 620, although internal plate 690 may be skewed slightly off-line from perpendicular, e.g., no more than about 20 degrees, preferably no more than 10 degrees, to change the fluid mechanics and alter the effective downward angle at which the bi-focal or near vision comes into view.
  • the skew angle may range from ⁇ 0.1 to +5 degrees, more specifically +0.5 to +2 degrees, still more specifically about +0.5 degrees relative to perpendicular from optical axis 620.
  • a first side of internal plate 690 is spaced apart from positive lens 614 to define a first (anterior) compartment of a first volume.
  • a second side of internal plate 690 is spaced apart from negative lens 616 to define a second (posterior) compartment of a second volume.
  • the first and second volumes may be the same or different relative to one another.
  • the anterior and posterior compartments may be provided with different volumes by installing internal plate 690 closer to either positive lens 614 or negative lens 616, and/or by skewing internal plate 690 as described above.
  • the first and second compartments are in fluid communication with one another to allow the flow of fluids 622, 624 between the compartments, for example when prosthesis 610 is tilted.
  • Internal plate 690 includes fenestrations 692 to permit the flow of fluids 622, 624 between the anterior and posterior compartments.
  • fenestrations 692 may comprise one, two, or more grooves or indentations situated about the outer periphery of internal plate 690.
  • Fenestrations 692 may possess alternative shapes than shown; for example, fenestrations 692 may comprise holes spaced from the periphery of internal plate 690.
  • At least one fenestration 692 is located in the upper half of internal plate 690, such as at the top of internal plate 690, and at least one fenestration 692 is located in the lower half, such as at the bottom of internal plate 690.
  • two fenestrations 692 are located in the upper half and two fenestrations 692 are located in the lower half of internal plate 690.
  • Fenestrations 692 are shown spaced equal distances from one another about the circumference of internal plate 690. It should be understood that the upper and lower halves of internal plate 690 may contain the same or a different amount of fenestrations 692 relative to the other, and that internal plate 690 may contain fewer or more fenestrations 692 than shown.
  • Internal plate 690 is retained inside optic body 612 using any suitable mechanism and method.
  • internal plate 690 is installed in a fixed and stationary position relative to lenses 614, 616.
  • internal plate 690 may have an outer periphery that is mounted to the inside of optic body 612, as best shown in Fig. 20.
  • optic body 612 includes a first case structure 612a connected to positive lens 614 and a second case structure 612b connected to negative lens 616.
  • Case structures 612a, 612b possess cylindrical flanges extending towards one another. When assembled, the flange of first case structure 612a is positioned radially inward of and mates with the flange of second case structure 612b.
  • Internal plate 690 rests on a shoulder of second case structure 612b, and is retained in place by the end of the cylindrical flange of first case structure 612a.
  • Fenestrations located about the periphery of internal plate 690 have a radial dimension that is greater than the width of the shoulder of second case structure 612b so that at least a portion of fenestrations remains exposed to permit the flow of fluid therethrough.
  • a hermetic seal may be established at the mating interface of case structures 612a, 612b by fusing the case materials or applying an adhesive.
  • a gasket also may be included, for example on the shoulder of second case structure 612b to create or supplement the hermetic seal.
  • Other modifications not shown may also be implemented.
  • internal plate 690 may optionally 6 044245
  • an internal chamber for holding a liquid or gas.
  • webs or filaments may be used for suspending internal plate 690 in a fixed position.
  • optically transmissive lower liquid 624 is present in a sufficient amount that orienting the optical axis horizontally positions the optical axis through lower liquid 624, bathing most of the anterior visual zone and the posterior visual zone in lower liquid 624, so that optical axis 620 intersects lower liquid 624 but not upper fluid 622, which may be a liquid, gas, or vacuum.
  • Optical axis 620 passes through the internal plate 690 in this modified embodiment.
  • Contact interface 623 between lower liquid 624 and upper fluid 622 is above optical axis 620 in the embodiment illustrated in Fig. 17, although it should be understood that contact interface 623 may be placed below optical axis 620, as shown in Figs. 5 and 6.
  • optical axis 620 of this modified embodiment is positioned at an angle relative to horizontal to translate lower liquid 624 on positive lens 614 and upper fluid 622 on negative lens 616.
  • Upper fluid 622 is present in the chamber in a sufficient amount that, throughout a range of effective angles ⁇ , optical axis 620 extends through upper fluid 622 at the vertex of negative lens 616.
  • most of the surface area of the anterior visual zone is immersed in lower liquid 624, and most of the posterior surface area of the posterior visual zone is immersed in upper fluid 622.
  • Upper fluid 622 and lower liquid 624 flow through fenestrations 692 to redistribute upper fluid 622 mostly in the posterior compartment and lower liquid 624 mostly in the anterior compartment.
  • the light rays first travel through lower liquid 624 before traveling through upper fluid 622.
  • the optical axis does not intersect through the contact interface 623. Rather, the light passes through internal plate 690, which displaces contact interface 623 away from and preferably out of the visual field, thereby eliminating or substantially eliminating contact interface 623 from the visual field.
  • internal plate 690 eliminates or substantially reduces the glare or aberration.
  • Internal plate 690 may be translated (shifted) towards either lens 614, 616 and/or skewed (tilted) as described above to assist in reducing the effect of or eliminating contact interface 623 from the visual field.
  • internal plate 690 in which the lower liquid 624 is the primary fluid, internal plate 690 is offset from center of the chamber towards posterior lens 616.
  • the first compartment between positive lens 614 and the anterior surface of internal plate 690 has a greater volume than the second compartment between negative lens 616 and the posterior side of internal plate 690.
  • the volume of the first compartment is approximately equal to the volume of lower liquid 624
  • the volume of the second compartment is approximately equal to the volume of upper fluid 622.
  • the upper fluid Upon downgaze, the upper fluid partially or completely fills the second compartment, and the lower fluid partially or completely fills the first compartment.
  • internal plate 690 may be shifted and/or skewed towards anterior lens 614.
  • the eye passes through an intermediate downward gaze at which the fluid interface 723 creates a prismatic effect for splitting light rays from a viewed object or objects into a first set of light rays 790 for producing a first locus of fixation at a first retinal region 792 and a second set of light rays 794 for producing the second locus of fixation at a second retinal region 796.
  • Angles associated with the intermediate downward gaze are typically encountered at the transition from the straight-ahead view to the downward gaze.
  • the first and second retinal regions are preferably different from one another, and more preferably are mutually exclusive, i.e., non- overlapping. At least one and optionally both of the first and second retinal regions 792, 796 falls partially or completely outside of a damaged macular region responsible for producing the scotoma.
  • the first retinal region 792 may comprise an area along the visual axis and thus may overlay the damaged macular region responsible for the scotomatous area, whereas the second retinal region 796 receiving light rays 794 as a result of the prismatic effect may lie in a more functional region outside of the damaged macular region responsible for the scotomatous area.
  • the range of angles ⁇ associated with the intermediate downward gaze is dependent upon the relative amounts of the upper fluid 722 and lower liquid 724 in the chamber. For the embodiment in which the optical axis passes through the lower liquid in the straight ahead gaze, the higher the level of the lower liquid in the chamber, the greater the angle ⁇ to cause the prismatic effect. Other factors, such as lens thickness, lens radius, and volume shaping may also affect the angle ⁇ . Generally, the range of angles ⁇ associated with the prism effect are within (and optionally throughout) a range of 30-60 degrees.
  • the anterior and posterior lenses may be spherical or aspheric. Aspheric lenses may compensate for astigmatism, coma, and higher order aberrations. It should be understood that this aspect of the invention may be practice with embodiments of the invention comprising a fluid interface in the line of sight.
  • Methods of making optic bodies are well known in the art and are described throughout the literature. These methods, which are suitable for use with the various aspects of the present invention, include, not necessarily by limitation, molding and lathing, with injection molding being perhaps the most commonly employed and well known of these methods.
  • the formation of a molded body with an internal chamber is well known in the injection molding and lathing arts.
  • Methods of gel-capsule manufacture as applied in the pharmaceutical industry may also be applied, as these methods describe introduction of fluids into capsules without leaving vacuum or air space within the capsule.
  • the anterior and posterior lens may be made as a unitary piece, or separately then joined together, such as by adhesive, fusion, or the like.
  • the optic body and lenses preferably comprise a material or materials biologically compatible with the human eye, and capable of injection molding, lathing, or the like.
  • the materials are preferably non-toxic, nonhemolytic, and non-irritant.
  • the optic body and lenses preferably are made of a material that will undergo little or no degradation in optical performance over its period of use. Unlike a contact lens, however, the material does not have to be gas permeable, although it may be.
  • the optic body may be constructed of rigid biocompatible materials, such as, for example, polymethylmethacrylate, or flexible, deformable materials, such as silicones, deformable acrylic polymeric materials, hydrogels and the like which enable the optic body to be rolled, deformed, or folded for insertion through a small incision into the eye.
  • rigid biocompatible materials such as, for example, polymethylmethacrylate, or flexible, deformable materials, such as silicones, deformable acrylic polymeric materials, hydrogels and the like which enable the optic body to be rolled, deformed, or folded for insertion through a small incision into the eye.
  • deformable materials such as silicones, deformable acrylic polymeric materials, hydrogels and the like which enable the optic body to be rolled, deformed, or folded for insertion through a small incision into the eye.
  • silicones such as silicones, deformable acrylic polymeric materials, hydrogels and the like which enable the optic body to be rolled, deformed, or folded for insertion through a small incision
  • the prosthesis surface may be modified with heparin or any other type of surface modification designed to increase biocompatibility and decrease possibility of the formation of capsular haze.
  • the prosthesis may also include a "ledge" for reducing formation of capsular haze.
  • the lenses may be treated, e.g., with a fluorinated substance, and made more or less hydrophilic/hydrophobic to create the desired fluidic motion and limit the adherence of the fluid to the lenses, thereby shortening transition time as gravity changes power from straight ahead to down gaze and back.
  • the prosthesis of this invention may include haptics, which are generally shown in Figs. 1 and 2, in which the haptics are designated by reference numeral 190.
  • Haptics generally serve to anchor the optics body in place in the eye. Haptics are usually attached directly to the lens body.
  • Various types of haptics are well known in the art, and their incorporation into this invention would be within the purview of an ordinary artisan having reference to this disclosure.
  • the typical haptic is a flexible strand of nonbiodegradable material fixed to the lens body.
  • suitable haptics for this invention may be made of one or more materials known in the art, including polypropylene, poly(methyi methacrylate), and any biocompatible plastic or material in use now or in the future that are used to hold the lens in place.
  • the haptics used with invention may possess any shape or construction adapted or adaptable for use with this invention for securing the lens body in place in the eye.
  • the haptics secure the optical lens within the capsular bag, whereas in the anterior chamber haptics may extend into the area defined between the anterior iris and posterior cornea.
  • an "iris claw" which hooks onto the fibers of the iris, or anterior chamber angle fixed haptics.
  • the upper and lower fluids may be introduced and retained in the optic body chamber prior to implanting or otherwise applying the prosthesis to a human eye.
  • the upper and lower fluids may be introduced into the chamber by any technique consistent with the objects of this invention.
  • a syringe or the like may be used for injecting the upper fluid and lower liquid into the chamber.
  • an entry port may be provided in the optic body for introducing the upper fluid and lower liquid into the chamber of the optic body.
  • the entry port may be formed during injection molding, by penetrating the optic body with a suitable hole- making instrument, such as a drill or pin, or it may established by the injecting instrument, e.g., syringe, during introduction of the fluids.
  • the location of the entry port is not critical. Other techniques may also be used to form the optic body.
  • the optic body with a vent port for expelling gas (usually air) from inside the optic body chamber as the upper and lower fluids are introduced through the entry port.
  • the vent may be separate from the entry port, or may consist of the entry port such that gas entrapped in the chamber is expelled as the upper and lower fluids are introduced into the chamber.
  • the chamber may be evacuated prior to the introduction of the upper fluid and the lower liquid.
  • the entry port and optional vent may be sealed to enclose the chamber in a known manner, such as by fusion or plugging with a compatible material, which may be the same or different than the material of which the optical body is comprised.
  • Both upper fluid and the lower liquid are preferably optically transmissive. It also is preferred that, when the fluids are emulsified by shaking or a position change, minimal mixing of the upper fluid and the lower liquid occur, and whatever mixing does occur quickly separates out again.
  • the substantially immiscible upper fluid and lower liquids are preferably optically transparent. It is within the scope of the invention for one or more of the optically transmissive fluids to possess a tint of any color that is not dense enough to significantly impede the transmission of light or the intended objects of this invention. It is within the scope of this invention for the upper fluid to be in the form of a liquid, gas or vacuum.
  • the term "fluid" as used herein encompasses the use of liquid, gas (e.g., air), or vacuum.
  • This invention is not limited to the use of only two fluids/liquids in the prosthesis.
  • Three or more fluids of different refractive indexes can be used to create a multi-power, multifocus prosthesis so that objects between far (pr) and near (pp) can be focused upon more clearly.
  • Tri-focals of this invention preferably have three liquids of different densities, with the refractive index of the fluids differing with fluid density.
  • Fluids that may be used for in the prosthesis body include, but are not limited to, those common to ophthalmic surgery, such as the following: water, aqueous humor, short-chain silicone oils, hyaluron, viscoelastics, polydimethyl siloxane, bis-phenyl propyl dimethicone, phenyl tri-methicone, di-phenyl-di-methyl siloxane copolymer (vinyl-terminated), cyclopentasiloxane, phenyl trimethicone, polydimethyl methyl phenyl siloxane, polymethyl phenyl siloxane, liquid chitosan, heparin, perfluoro-n-octane (perfluoron), perfiuoroperhydrophenanthrene, perfluoromethyldecalin, perfluoropentane, perfluoro-l,3-dimethyl cyclohexane, per
  • fluorocafbon liquids may be selected for use as the lower liquid and/or the upper fluid.
  • Representative fluorocarbon fluids that may be used for providing the desired refractive properties of this invention include haloalkanes.
  • Representative haloalkanes that may be useful include trichloromonofluoromethane, dichlorodifluoromethane, monochlorotrifluoromethane, bromotrifluorornethane, dichloromonofiuoromethane, monochlorodifluoromethane, dichlorotetrafluoroethane.
  • fluorocarbons include 2,2,2-trifluoroethanol, octofluoropentanol-1, dodecafluoroheptanol-1.
  • Other liquids include methanol, acetonitrile, ethyl ether, acetone, ethanol, methyl acetate, propionitrile, 2,2 dimethyl butane, isopropyl ether, 2-methyl pentane, ethyl acetate, acetic acid, D-mannitol, and D-sorbitol.
  • polymethyl/silicon liquid species can be used, including, by way of example, the following: tetrachlorophenylsilsesquixane-dimethyl siloxane copolymer, poly(methylsilsesquioxane, 100% methyl), poly(methylhydridosilsesquioxane, 90%), poly(phenylsilsesquioxane), 100% phenyl, poly(phenyl-rnethylsilsesquioxane 90% phenyl 10% methyl), dimethicone copolyol PPG-3 oleyl ether (aka alkyl polyether), hydroxymethyl acetomonium PG dimethicone (aka betaine), amino propyl dimethicone (aka amine).
  • tetrachlorophenylsilsesquixane-dimethyl siloxane copolymer poly(methylsilsesquioxane, 100% methyl), poly(methylhydridosilsesquioxane, 90%), poly
  • aqueous salts include sodium chloride, calcium chloride, zinc chloride, potassium chloride, and sodium nitrate (referred to herein as "NaN")- Generally, the concentration of the salts and sugars should be no higher than their saturation points.
  • the prosthesis can be inserted into the posterior chamber of the human eye, preferably into the capsular bag posterior to the iris to replace the physiological (natural) lens in the capsular bag positioned using known equipment and techniques.
  • Posterior implantation is preferred because, among other reasons, this is the location from which the physiological lens is removed.
  • intra-capsular cataract extraction and IOL implantation utilizing clear corneal incision (CCI), phacoemulsification or similar technique may be used to insert the intraocular lens after the physiological crystalline lens has been removed from the capsular bag.
  • the incision into the eye may be made by diamond blade, a metal blade, a light source, such as a laser, or other suitable instrument.
  • the incision may be made at any appropriate position, including along the cornea or sclera. It is possible to make the incision "on axis", as may be desired in the case of astigmatism. Benefits to making the incision under the upper lid include reduction in the amount of stitching, cosmetic appeal, and reduced recovery time for wound healing.
  • the prosthesis is preferably rolled or folded prior to insertion into the eye, and may be inserted through a small incision, such as on the order of about 3 mm.
  • the term "capsular bag” includes a capsular bag having its front surface open, torn, partially removed, or completely removed due to surgical procedure, e.g., for removing the physiological lens, or other reasons.
  • capsular bag 160 has an elastic posterior capsule, and an anterior capsular remnant or rim defining an opening through which the physiological lens was removed.
  • the prosthesis may be inserted in the anterior chamber between the cornea and the iris.
  • the prosthesis In an anterior chamber implant, the prosthesis is generally situated forward of, or mounted to, the iris.
  • Selection of appropriate fluids can be determined with the assistance of SnelPs Law and is based on the Index of Refraction (ER.) of the media.
  • ER. Index of Refraction
  • Different non-opaque media have their own specific index of refraction, and mixed media take on their own individual index of refraction. If two media are placed in contact with one another but do not mix, light will be refracted as it travels from the first medium into the second medium. If a third medium is provided, the light will be refracted again as it passes between the second and third media.
  • the prosthesis of the various aspects and embodiments described herein may be used in one or both eyes of the subject. For example, it may be desirable to have the prosthesis serve as a telescope in one eye, but not the other.
  • the human eye was first modeled as a typical or schematic adult human emmetrope, as described in the Optical Society of America Handbook. Each of the models described below is for a posterior chamber IOL design. The following assumptions were made for the human eye for the purposes of the calculations. The model was assumed to have spherical surfaces only (whereas the real cornea and lens are actually aspherics). Each structure of the schematic human eye was assumed to be made of a material having a uniform or homogenous index (whereas in the real human eye, the index of refraction may vary somewhat through each structure of the eye). The model also assumed that the capsular bag walls were very thin and parallel, i.e., non-existent. The lens was assumed to have symmetric radius, Le., spherical.
  • the pr was assumed to be 10 meters. Three wavelengths with equal weighting were used for optimization and evaluation: 510 nm, 560 nm, and 610 nm to provide a simple approximation of the human photopic response. Walker, Bruce H., Optical Design for visual Systems, SPIE Press (2000).
  • the Abbe wavelength dispersion is assumed to be 55.0 for all natural materials. The indices at other wavelengths were calculated based on no and the dispersion value. Modeling was performed for small pupil sizes of 1.5 mm. The initial values assumed for the eye are listed below in Table 1.
  • the lower liquid is the primary liquid and has a lesser refractive index than the upper liquid.
  • the upper liquid has a greater refractive index and imparts accommodative power (+ power) on down gaze by increasing the effective power of the posterior IOL surface.
  • Models were made for the combinations of fluids in Table 2. The index of refraction value were either taken as reported in the literature at 37°C (body temperature) in a saturated solution, or were estimated based on calculations using three (3) wavelengths (of 510 run, 560 nm, and 610 nm).
  • ** n ⁇ l and no2 are refractive index of lower liquid and the upper liquid, respectively, at or about its saturation limit at 589 nm wavelength.
  • Rl and R2 are the radius of curvature of the anterior surface and the posterior surface, respectively, in millimeters.
  • the shapes of the anterior and posterior walls were calculated for hypothetical cases by modifying the adult human emmetrope model to simulate an IOL.
  • the crystalline lens material was replaced with the lower fluid to simulate horizontal pr gaze (at 10 m), and the pp (250 mm) was modeled in a directly vertical 90° downward gaze angle using two liquids with the interface perpendicular to the optical axis.
  • the posterior radius of the lens was selected to obtain the needed change of power with the upper liquid introduced to accommodate for pp (at about 250 mm).
  • Gaze angles of less than 90° were then evaluated without re-optimizing the model parameters. Specifically, gaze angles of 50° and 70° were investigated. The 90°, 70°, and 50°
  • gaze angles were each evaluated at the following five field points of 0°, ⁇ 7.5°, and
  • the IOL schematics are laid out as though plotted on a chart, with the actual fluid's refractive index along the horizontal axis (abscissa) and the difference in the index values of the two fluids on the vertical axis (ordinate). Internal to the lens schematics, the fluids are labeled with the following symbols:
  • -H- a liquid having an index of refraction greater than the humors and the adjacent "H-" liquid; a liquid having an index of refraction lower than the humors; a liquid having an index of refraction lower than the humors and the adjacent "-" liquid.
  • the cornea (not shown) is to the left of the IOL schematics, and the iris is shown immediately to the left of the IOL schematics.
  • the surface that produces the optical power change (pr to pp adaptation) is shown with a double line.
  • Fluid combinations S9 and SlO were less preferred due to the steep curvatures of Rl (anterior surface) or R2 (posterior surface).
  • the upper liquid is the primary liquid and has a greater refractive index than the lower liquid.
  • the lower liquid imparts accommodative power (+ power) on down gaze by increasing the effective power of the lens.
  • the shapes of the anterior and posterior walls were calculated for hypothetical cases by modifying the adult human emmetrope model to simulate an IOL.
  • the crystalline lens material was replaced with the upper fluid to simulate horizontal pr gaze (at 10 m), and the pp (at about 250 mm) was modeled in a directly vertical 90° downward gaze angle using two fluids with the interface perpendicular to the optical axis.
  • the anterior radius of the lens was selected to obtain the needed change of power with the lower liquid introduced to accommodate for pp. Again, assumptions made above for the model eye were applied, as needed. Gaze angles of less than 90° were then evaluated without re-optimizing the model parameters. Table 5
  • Fluid combinations S5 ⁇ S8 ⁇ S9 ⁇ SlO', and S 12' were less preferred due to the small sizes of the IOL Rl and/or R2.
  • the upper liquid is the primary liquid and has a smaller refractive index than the lower liquid.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne une prothèse, qui inclut une lentille positive, une lentille négative située à une certaine distance de la lentille positive et alignée sur cette dernière le long d'un axe optique, et un corps optique soutenant la lentille positive et la lentille négative dans une relation à une certaine distance l'une de l'autre afin d'établir une chambre entre les lentilles. Un fluide primaire de transmission optique est contenu dans la chambre du corps optique. Le fluide primaire est situé de telle manière que l'orientation de l'axe optique dans une orientation horizontale pour une vision de loin positionne l'axe optique à travers le fluide primaire. Un fluide secondaire de transmission optique est contenu dans la chambre du corps optique et est pratiquement immiscible avec le fluide primaire. Le fluide secondaire a une densité et un indice de réfraction différents par rapport au fluide primaire. Le fluide secondaire est situé de telle manière que l'orientation de l'axe optique pour une vision de près dans une plage d'angles descendants effectifs en relation à l'orientation horizontale positionne l'axe optique de façon à ce qu'il se prolonge à travers le fluide primaire et le fluide secondaire. L'invention concerne également des procédés connexes.
PCT/US2006/044245 2005-11-14 2006-11-14 Prothese multifocale, et procedes de fabrication et d'utilisation de celle-ci WO2007059160A2 (fr)

Priority Applications (4)

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EP06837602A EP1954213A4 (fr) 2005-11-14 2006-11-14 Prothese multifocale, et procedes de fabrication et d'utilisation de celle-ci
CA002631261A CA2631261A1 (fr) 2005-11-14 2006-11-14 Prothese multifocale, et procedes de fabrication et d'utilisation de celle-ci
JP2008541290A JP4931932B2 (ja) 2005-11-14 2006-11-14 多焦点の補綴およびそれを使用し製造する方法
US12/047,164 US8657877B2 (en) 2005-11-14 2008-03-12 Multi-focal prosthesis, and methods for making and using same

Applications Claiming Priority (2)

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US73587905P 2005-11-14 2005-11-14
US60/735,879 2005-11-14

Related Child Applications (1)

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US8961392B2 (en) 2000-04-14 2015-02-24 Attenuex Technologies, Inc. Delivery system for inflatable implant
US9044209B2 (en) 2000-04-14 2015-06-02 Attenuex Technologies, Inc. Method of removing an inflated implant
US9675445B2 (en) 2009-05-27 2017-06-13 See Again Europe Limited Intraocular lens systems and methods
US9801658B2 (en) 2012-08-10 2017-10-31 Attenuex Technologies, Inc. Removal device
US10327880B2 (en) 2000-04-14 2019-06-25 Attenuex Technologies, Inc. Attenuation device for use in an anatomical structure
US10959836B2 (en) 2013-08-12 2021-03-30 Syneos Health International Limited Intraocular lens system
US11197981B2 (en) 2019-02-07 2021-12-14 Solace Therapeutics, Inc. Pressure attenuation device

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US7374532B2 (en) 2000-04-14 2008-05-20 Attenuex Technologies, Inc. High vapor pressure attenuation device
US6682473B1 (en) 2000-04-14 2004-01-27 Solace Therapeutics, Inc. Devices and methods for attenuation of pressure waves in the body
US8579971B2 (en) 2007-08-13 2013-11-12 Garth T. Webb Inflatable intra ocular lens/lens retainer

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Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10327880B2 (en) 2000-04-14 2019-06-25 Attenuex Technologies, Inc. Attenuation device for use in an anatomical structure
US8961392B2 (en) 2000-04-14 2015-02-24 Attenuex Technologies, Inc. Delivery system for inflatable implant
US9044209B2 (en) 2000-04-14 2015-06-02 Attenuex Technologies, Inc. Method of removing an inflated implant
US9615911B2 (en) 2000-04-14 2017-04-11 Attenuex Technologies, Inc. Delivery system for inflatable implant
US10383510B2 (en) 2000-04-14 2019-08-20 Solace Therapeutics, Inc. Implant with high vapor pressure medium
US9675445B2 (en) 2009-05-27 2017-06-13 See Again Europe Limited Intraocular lens systems and methods
NL2008105C2 (en) * 2012-01-11 2013-07-15 Procornea Holding Bv Intraocular lens.
US9801658B2 (en) 2012-08-10 2017-10-31 Attenuex Technologies, Inc. Removal device
US10799268B2 (en) 2012-08-10 2020-10-13 Solace Therapeutics, Inc. Methods and systems for performing a medical procedure
US10543071B2 (en) 2012-08-10 2020-01-28 Solace Therapeutics, Inc. Methods and systems for performing a medical procedure
US10531894B2 (en) 2012-08-10 2020-01-14 Solace Therapeutics, Inc. Methods and systems for performing a medical procedure
US10959836B2 (en) 2013-08-12 2021-03-30 Syneos Health International Limited Intraocular lens system
US11633274B2 (en) 2013-08-12 2023-04-25 Syneos Health International Limited Intraocular lens system
US11197981B2 (en) 2019-02-07 2021-12-14 Solace Therapeutics, Inc. Pressure attenuation device

Also Published As

Publication number Publication date
JP2009515651A (ja) 2009-04-16
CA2631261A1 (fr) 2007-05-24
EP1954213A2 (fr) 2008-08-13
WO2007059160A3 (fr) 2007-10-04
JP4931932B2 (ja) 2012-05-16
EP1954213A4 (fr) 2012-10-17

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